- Laboratory test results may require additional information beyond the result value for correct handling and interpretation, including units, reference range, harmonization status of the test, and identifiers for device, test kit, kit version, reagent lot, and calibrator lot. Not all of these elements are included in current messaging standards for the full result reporting path.
- Current versions of the IHE LAW and LTW profiles support communication of lot information only within an order filling system and only for QC specimens. Reporting test harmonization status is not supported in current versions of communication standards. See additional discussion in “Representing Laboratory Values/Results.”
- LAW – Laboratory Analytical Workflow Profile – The LAW Profile defines the physical connection, message definitions (based on the HL7 Messaging Standard v2.5.1), and workflow definitions between instruments, middleware, and LIS systems in the laboratory. IICC collaborated with the IHE Pathology and Laboratory Medicine (PaLM) domain to develop the LAW Profile. See: http://ivdconnectivity.org/law-profile/
- The LIVD – Digital format for Publication of LOINC to Vendor IVD Test results defines the digital publication of LOINC using vendor defined IVD tests associated with a set of pre-defined LOINC codes. LIVD helps assure that laboratory personnel select the appropriate LOINC codes for IVD tests used by their laboratory. LIVD also allows LIS systems to automatically map the correct in vitro diagnostic (IVD) vendor test result to a LOINC code. LIVD was developed by the IVD Industry Connectivity Consortium in collaboration with SHIELD.
- SHIELD (Systemic Harmonization and Interoperability Enhancement for Laboratory Data) is a multi-agency/stakeholder public-private partnership of over 70 stakeholders across government (FDA, CDC, NIH, ONC, CMS), industry, EHR vendors, laboratories, standards developers, professional organizations and academia, focused on the development/adoption and implementation of data standards to improve laboratory data interoperability.
- For additional context, please refer to the Guidance for Industry and Food and Drug Administration Staff “Logical Observations Identifiers Names and Codes (LOINC) for In Vitro Diagnostics.”
- Note that the LIVD Implementation Specification (LIVD – Digital Format for Publication of LOINC to Vendor IVD Test Results) has not been vetted through a Voluntary Consensus Standards Body (VCSB) as defined in OMB Circular A-1195.
The Laboratory Analytical Workflow (LAW) Profile is part of the Pathology and Laboratory Medicine (PaLM) domain and defines plug-n-play connectivity between instruments, middleware, and LIS systems in the laboratory. It standardizes the data flow of IVD patient and QC test work order steps and results. LAW is incorporated into the PaLM Volume 1 and Volume 2 Technical Framework (see link in Table above) and also can be found here.
LAW provides the following capabilities, some not currently supported by LIS2 (ASTM):
- Support for IA, CC, hematology, microbiology, and molecular testing
- Unique identification of each order request at the test or test panel level
- Improved query for orders
- Selection of query as the default mode
- Simplified order download
- Ability for an analyzer to accept or reject orders
- Improved device identification for test logging
- Contributing substance identification for test logging
- Basic and enhanced message interface to support IVD instrument rule evaluation
- LOINC identification of test requests and observations (LIVD format recommended)
- Unique identification of runs
- Support for hematology images, graphs, and plots
- Support for transmission of raw values
- Support for rerun and reflex testing
- HL7 2.5.1 based
- Supports LOINC®, JLAC10, and UCUM